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Found 47 results
510(k) Data Aggregation
K Number
K041433Device Name
BRIGHT GOLD XH
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2004-08-19
(83 days)
Product Code
EJS
Regulation Number
872.3060Why did this record match?
Product Code :
EJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Brite Gold XH alloy intended to be used for onlays, % crowns, crowns and short span bridges PFM crowns
Device Description
Bright Gold
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K Number
K040436Device Name
SIMIDUR SUPERIOR
Manufacturer
WIELAND DENTAL + TECHNIK GMBH & CO. KG
Date Cleared
2004-03-05
(15 days)
Product Code
EJS, ETS
Regulation Number
872.3060Why did this record match?
Product Code :
EJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Simidur Superior is a palladium - silver ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- Crowns
- Short span bridges
- Long span bridges
- Removable partials
and can be used for
- Telescopic and milling work
Simidur Superior can be veneered with suitable dental ceramics as well as with dentalcomposites.
Device Description
SIMIDUR SUPERIOR is a palladium-silver ceramic alloy with high contents of precious metals (87,0%), intended for dental technicians to fabricate dental restorations.
It has an indication for use which ranges from single crowns up to long span bridges with two or more pontics. In addition, it can be used for removable partials as well as for telescopic and milling work.
SIMIDUR SUPERIOR is highly corrosion resistant and has aan excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
SIMIDUR SUPERIOR can be veneered with suitable dental ceramics and with dental composites.
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K Number
K022252Device Name
STERNGOLD 1, MODEL 1127781
Manufacturer
STERNGOLD
Date Cleared
2002-09-19
(69 days)
Product Code
EJS
Regulation Number
872.3060Why did this record match?
Product Code :
EJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Precious Alloy for use in Crown and Bridge Dental Restorations.
Device Description
Stengold 1 is a Yellow Crown and Bridge Alloy.
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K Number
K022469Device Name
ECO E4
Manufacturer
WIELAND DENTAL + TECHNIK GMBH & CO. KG
Date Cleared
2002-09-18
(54 days)
Product Code
EJS, E12
Regulation Number
872.3060Why did this record match?
Product Code :
EJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Eco E4 is a silver-palladium casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/onlays - Crowns - Short span bridges - Long span bridges Eco E4 can be veneered with suitable dental composites.
Device Description
Eco E4 is a high strength silver-palladium casting alloy, intended for dental technicians to fabricate dental restorations. It consists of silver, palladium and gold (93,5%) as well as of copper and zinc. Eco E4 has an indication for use which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics. It complies with the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
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K Number
K021367Device Name
STERNGOLD 66, MODEL #1180230
Manufacturer
STERNGOLD
Date Cleared
2002-05-16
(16 days)
Product Code
EJS
Regulation Number
872.3060Why did this record match?
Product Code :
EJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Precious Alloy for use in Crown and Bridge Dental Restorations.
Device Description
Sterngold 66 is a White Crown and Bridge Alloy.
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K Number
K020192Device Name
SIMIDUR S2
Manufacturer
WIELAND DENTAL + TECHNIK GMBH & CO. KG
Date Cleared
2002-03-15
(52 days)
Product Code
EJS
Regulation Number
872.3060Why did this record match?
Product Code :
EJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Simidur S2 is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Crowns, Short span bridges, Long span bridges, Removable partials and can be used for - Telescopic and milling work. Simidur S2 can be veneered with suitable dental ceramics as well as with dentalcomposites.
Device Description
Simidur S2 is a palladium-base ceramic alloy with a high content of noble metals (81% ), intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from single crowns up to long span bridges with two it has an indication which farges wortials. It is free of silver and suitable for telescopic and milling work. Simidur S2 is highly corrosion resistant and has an excellent biocompatibility. It fully Simidal U2 is highly ochooled ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur S2 can be veneered with suitable dental ceramics and with dental composites.
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K Number
K020194Device Name
SIMIDUR KF PLUS
Manufacturer
WIELAND DENTAL + TECHNIK GMBH & CO. KG
Date Cleared
2002-03-15
(52 days)
Product Code
EJS
Regulation Number
872.3060Why did this record match?
Product Code :
EJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Simidur KF plus is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work. Simidur KF plus can be veneered with suitable dental ceramics as well as with dentalcomposites.
Device Description
Simidur KF plus is a palladium-base ceramic alloy (79,7% Palladium), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work. Simidur KF plus is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur KF plus can be veneered with suitable dental ceramics and with dental composites.
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K Number
K020195Device Name
SIMIDUR S1S
Manufacturer
WIELAND DENTAL + TECHNIK GMBH & CO. KG
Date Cleared
2002-03-15
(52 days)
Product Code
EJS
Regulation Number
872.3060Why did this record match?
Product Code :
EJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Simidur S1S is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Crowns, Short span bridges, Long span bridges, Removable partials and can be used for - Telescopic and milling work. Simidur S1S can be veneered with suitable dental ceramics as well as with dentalcomposites.
Device Description
Simidur S1S is a palladium-base ceramic alloy (56,0% Palladium), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work. Simidur S1S is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur S1S can be veneered with suitable dental ceramics and with dental composites.
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K Number
K014042Device Name
D.SIGN 84
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2002-02-22
(77 days)
Product Code
EJS
Regulation Number
872.3060Why did this record match?
Product Code :
EJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
d-Sign 84 is intended to be used with conventional feldpathic porcelains. Also a-olgh 04 intended to be assa mas, conus crowns, conus crowns, posts, attachments, short and long span bridges, and PFM crowns.
Device Description
Not Found
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K Number
K013809Device Name
D.SIGN 59
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2002-02-07
(84 days)
Product Code
EJS
Regulation Number
872.3060Why did this record match?
Product Code :
EJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
d.SIGN 59 alloy intended to be used for onlay, ¾ crows, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.
Device Description
d.SIGN 59 alloy
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